ID:
501324
Duration (hours):
80
CFU:
8
SSD:
CHIMICA FARMACEUTICA
Year:
2025
Overview
Date/time interval
Primo Semestre (29/09/2025 - 23/01/2026)
Syllabus
Course Objectives
The course allows the acquisition of basic and specific knowledge for the quality control of drugs and medicines. It aims to provide students with an overview of the chemical and instrumental analysis methodologies used for the structural identification and qualitative analysis of drugs and excipients registered in the current Official Pharmacopoeias (with particular reference to the Italian Pharmacopoeia and the European Pharmacopoeia, EP), for the control of purity (determination of impurities), and for the control of their stability. The course (which includes mandatory single and group laboratory activities) provides students with the ability to identify unknown substances registered in the Pharmacopoeia through the application of chemical and instrumental methodologies.
At the end of the course, the expected learning outcomes are:
1. knowledge of the methods for defining the main chemical-physical characteristics (e.g. solubility, melting point, reactivity of the different functional groups) of drugs on the basis of their chemical structure;
2. the ability to apply theoretical knowledge of spectroscopic (UV-VIS, IR, NMR), separation (TLC, HPLC, GC) and mass spectrometry (MS) techniques for drug recognition;
3. knowledge of the methods of isolation and purification of biologically active molecules (extraction, crystallization) and their application in pharmaceutical analysis;
4. the ability to understand and discuss pharmacopoeia monographs.
5. the ability to analyze and solve problems related to the chemical and instrumental identification of active ingredients and excipients even in complex mixtures.
At the end of the course, the expected learning outcomes are:
1. knowledge of the methods for defining the main chemical-physical characteristics (e.g. solubility, melting point, reactivity of the different functional groups) of drugs on the basis of their chemical structure;
2. the ability to apply theoretical knowledge of spectroscopic (UV-VIS, IR, NMR), separation (TLC, HPLC, GC) and mass spectrometry (MS) techniques for drug recognition;
3. knowledge of the methods of isolation and purification of biologically active molecules (extraction, crystallization) and their application in pharmaceutical analysis;
4. the ability to understand and discuss pharmacopoeia monographs.
5. the ability to analyze and solve problems related to the chemical and instrumental identification of active ingredients and excipients even in complex mixtures.
Course Prerequisites
The topics addressed during the course require the knowledge and skills provided by the courses in General and Inorganic Chemistry, Analytical Chemistry and Organic Chemistry, with particular emphasis on the chemical nomenclature of inorganic and organic compounds, the reactivity of inorganic compounds and knowledge of the functional groups and their reactivity.
Teaching Methods
The course includes lectures and laboratory activities. The frontal lessons (6 CFU) are carried out through presentations (PowerPoint) and in-depth analysis (whiteboard and material made available on the Kiro platform). The theoretical lessons, necessary to understand the fundamental principles of analytical techniques and the reactivity of functional groups, are constantly integrated with practical examples. The teaching material is made available on the Kiro platform.
During laboratory exercises (2 CFU) students are guided in the analysis of inorganic, organic and metal-organic substances using chemical reactions and instrumental techniques. .
Group tutoring activities are planned for the assignment of structures using instrumental techniques (problem based learning).
Attendance at lab activities is mandatory, attendance at lectures is strongly recommended
During laboratory exercises (2 CFU) students are guided in the analysis of inorganic, organic and metal-organic substances using chemical reactions and instrumental techniques. .
Group tutoring activities are planned for the assignment of structures using instrumental techniques (problem based learning).
Attendance at lab activities is mandatory, attendance at lectures is strongly recommended
Assessment Methods
The learning assessment includes ongoing and final written tests.
There are two ongoing tests planned, one on the chemical recognition part and one on the instrumental analysis part. The exam is considered passed if both tests are positive. To access the test, you must pass two functional group identification questions.
The written test includes 4 multiple choice and/or semi-open questions, 6 open questions regarding both the part of recognition of biologically active molecules through chemical reactions and the part relating to instrumental methods.
The possibility of using the Kiro-testing platform is expected. The duration of the test is 2 hours.
The evaluation of the test is carried out out of thirty, the final mark (8 CFU) will take into account the mark of the written test (6/8) and laboratory test (2/8).
Students have questions available for the exam simulation.
There are two ongoing tests planned, one on the chemical recognition part and one on the instrumental analysis part. The exam is considered passed if both tests are positive. To access the test, you must pass two functional group identification questions.
The written test includes 4 multiple choice and/or semi-open questions, 6 open questions regarding both the part of recognition of biologically active molecules through chemical reactions and the part relating to instrumental methods.
The possibility of using the Kiro-testing platform is expected. The duration of the test is 2 hours.
The evaluation of the test is carried out out of thirty, the final mark (8 CFU) will take into account the mark of the written test (6/8) and laboratory test (2/8).
Students have questions available for the exam simulation.
Texts
Analisi Farmaceutica David G. Watson, EdiSES;
Analisi Farmaceutica Metodi di Riconoscimento e di separazione, Cavrini V., Andrisano V., Casa Editrice Esculapio;
Savelli-Bruno: Analisi chimico farmaceutica;
“Pharmaceutical Chemistry - Vol. 2 (Drug Analysis), H. J. Roth, K. Eger, R. Troschutz Ellis Horwood Series in Pharmaceutical Technology.
Farmacopea Ufficiale Italiana
Analisi Farmaceutica Metodi di Riconoscimento e di separazione, Cavrini V., Andrisano V., Casa Editrice Esculapio;
Savelli-Bruno: Analisi chimico farmaceutica;
“Pharmaceutical Chemistry - Vol. 2 (Drug Analysis), H. J. Roth, K. Eger, R. Troschutz Ellis Horwood Series in Pharmaceutical Technology.
Farmacopea Ufficiale Italiana
Contents
The course deals, from a theoretical point of view, with the analysis methods commonly used in the qualitative analysis of drugs, referring to official texts (in particular to the methods reported in the Official Italian and European Pharmacopoeia).
Chemical analysis: Organoleptic characteristics, solubility tests and combustion behavior of substances of pharmaceutical interest. Determination of the melting point.
Recognition of substances through chemical assays: elementary organic analysis and main reactions of the functional groups (double and triple olefinic bonds, aromatic systems, conjugated π systems, alcoholic, ether, phenolic, carbonyl, carboxyl, ester, amide, amino group); Isolation and purification methods (extraction, crystallization)
Instrumental analysis: theoretical principles and applications to the recognition of substances registered in the pharmacopoeia using spectroscopic and separation techniques: UV, IR, 1H-NMR, polarimetry; TLC, HPLC, GC, MS.
Criteria for selection and application of spectroscopic, chromatographic and mass spectrometric techniques in relation to the analytical problem.
Instrumental methods and specific tests for identifying drugs reported by the Pharmacopoeia.
The part of the course dedicated to the laboratory includes:
- General scheme of analysis of drugs and excipients registered in the Pharmacopoeia;
- Combustion test: distinction between organic, metal-organic and inorganic substances
- Recognition of organic substances
a) Elemental analysis (search for sulfur and halogens), study of solubility according to pharmacopoeia;
b) Specific reactions of functional groups and compound classes
c) Determination of the melting point
- Recognition of inorganic substances
a) Solubility
b) Analysis of inorganic substances soluble in water or mineral acids (cation identification reactions according to periodic method and anion identification reactions)
c) Analysis of inorganic substances insoluble in water or mineral acids
- Recognition of metal-organic substances
a) Analysis of the organic portion and the inorganic cation as described in the previous points
- Tests for the recognition of unknown samples, consisting of individual inorganic, metal-organic and organic substances, registered in the Pharmacopoeia also by means of spectra.
-Identification and characterization of drugs and their impurities using instrumental techniques (TLC, interpretation of spectra)
Chemical analysis: Organoleptic characteristics, solubility tests and combustion behavior of substances of pharmaceutical interest. Determination of the melting point.
Recognition of substances through chemical assays: elementary organic analysis and main reactions of the functional groups (double and triple olefinic bonds, aromatic systems, conjugated π systems, alcoholic, ether, phenolic, carbonyl, carboxyl, ester, amide, amino group); Isolation and purification methods (extraction, crystallization)
Instrumental analysis: theoretical principles and applications to the recognition of substances registered in the pharmacopoeia using spectroscopic and separation techniques: UV, IR, 1H-NMR, polarimetry; TLC, HPLC, GC, MS.
Criteria for selection and application of spectroscopic, chromatographic and mass spectrometric techniques in relation to the analytical problem.
Instrumental methods and specific tests for identifying drugs reported by the Pharmacopoeia.
The part of the course dedicated to the laboratory includes:
- General scheme of analysis of drugs and excipients registered in the Pharmacopoeia;
- Combustion test: distinction between organic, metal-organic and inorganic substances
- Recognition of organic substances
a) Elemental analysis (search for sulfur and halogens), study of solubility according to pharmacopoeia;
b) Specific reactions of functional groups and compound classes
c) Determination of the melting point
- Recognition of inorganic substances
a) Solubility
b) Analysis of inorganic substances soluble in water or mineral acids (cation identification reactions according to periodic method and anion identification reactions)
c) Analysis of inorganic substances insoluble in water or mineral acids
- Recognition of metal-organic substances
a) Analysis of the organic portion and the inorganic cation as described in the previous points
- Tests for the recognition of unknown samples, consisting of individual inorganic, metal-organic and organic substances, registered in the Pharmacopoeia also by means of spectra.
-Identification and characterization of drugs and their impurities using instrumental techniques (TLC, interpretation of spectra)
Course Language
Italian
More information
Written exams are intended to be IN PRESENCE
Degrees
Degrees
PHARMACY
Single-cycle Master’s Degree
5 years
No Results Found
People
People (2)
No Results Found